TWN Info Service on WTO and Trade Issues (Jan10/05)
27 January 2010
Third World Network

WHO: Virus-Benefit Sharing Working Group set up, pandemic flu response to be reviewed
Published in SUNS #6849 dated 26 January 2010

Geneva, 25 Jan (Sangeeta Shashikant) -- The response to the H1NI pandemic influenza and unfinished business in respect of the pandemic influenza preparedness framework for virus and benefit sharing were a key focus of the 126th session of the Executive Board meeting last week.

These issues surfaced during the WHO Director-General's address to the Executive Board (EB), which met from 18-23 January, as well as under the agenda items of "International Health Regulation" and "Pandemic Influenza Preparedness: sharing of influenza viruses and access to vaccines and other benefits" (PIP framework).

On the first day of the EB on 18 January, Director-General Dr. Margaret Chan dedicated 23 out of 56 paragraphs of her address at the EB (in document EB 126/2) to the issue of the H1N1 pandemic influenza and the response to the pandemic.

While her response to the pandemic received "praise" from some Members, country interventions clearly revealed underlying dissatisfaction and frustration with the response.

During the discussion on the Report by the Director-General (DG) on the Implementation of the International Health Regulations (IHR) 2005 (EB 126/5), several countries called for the WHO to review its response to the pandemic, including the definition of "pandemic".

The call for this review comes amidst recent news reports about the apparent undeclared close financial ties between the pharmaceutical companies and the Strategic Advisory Group of Experts (SAGE), a WHO advisory group on vaccines and immunization, and questions surrounding the definition of "pandemic".

The discussion on the PIP framework further revealed discontentment over the response. Several developing countries pointed to the lack of access to anti-virals and vaccines during the H1N1 pandemic; the need for benefit sharing since viruses were being shared; and to ensure that IPRs (intellectual property rights) do not impede public health. They also called for a Member-driven process to finalize the remaining elements of the PIP framework for virus and benefit sharing.

(According to the Director-General's report, "To date, well over 23,000 viruses and other specimens have been submitted to the WHO Network laboratories for analysis".)

The agenda item on International Health Regulations (IHR) concluded with Dr Chan promising to activate the IHR Review Committee to review the functioning of the IHR, as well as the scope and effectiveness of the global response and the WHO Secretariat' response to the H1N1 pandemic, as well as identify the lessons learned.

(The IHR is a legal framework for the management of the global response to the pandemic. The H1N1 outbreak has been the first test of the IHR.)

Dr Chan also said that she would organize a meeting for the review before the World Health Assembly (WHA) in May, although she envisaged that the review would not be completed by then. She further said that she intended to provide an interim report in May and that the review would continue after May.

With regards to the PIP framework, it was agreed that an open-ended working group for negotiations between Member states would be convened on the basis of the outcome of the Intergovernmental Meeting (A62/5 Add. 1).

The meeting would be convened on 10-12 May just prior to the WHA and it would focus on the remaining elements of the framework and report to the May WHA. The EB also requested the DG to facilitate the process.

Canada requested that the DG's proposals (contained in EB126/4) on finalizing the remaining elements of the PIP framework be included as a reference.

The agreement was reached after informal consultations among countries. Canada (with the support of other developed countries, according to sources) proposed setting up a working group during the WHA in May and for this purpose, distributed an informal text. This was objected to by several developing countries during the consultations on the basis of the heavy WHA agenda. They instead proposed a session before the WHA.

According to sources, the Secretariat was also not keen on holding a negotiation session before the WHA, citing as a reason financial and other resource limitations. However, ultimately, the developed countries and the Secretariat both capitulated to the demand for an open-ended working group session prior to the WHA.

The push for a PIP framework that includes fair and equitable benefit sharing was initiated at the 2007 WHA following Indonesia's reluctance to share viruses if benefit sharing was not equally forthcoming after a serious H5N1 avian flu outbreak. Indonesia argued that it shared virus samples by signing a Standard Material Transfer Agreement (SMTA) and these viruses were used to produce vaccines, which were neither available nor affordable for developing countries.

It also emerged that patent claims had been filed over several of the viruses and parts thereof that were contributed to laboratories under the authority of the WHO.

Ongoing negotiations in the form of an Intergovernmental Meeting (IGM) on the PIP framework came to a halt last year, as developed countries refused to renew its mandate. It was then agreed that the DG would initiate a transparent process to finalize the remaining elements of the PIP framework, including the SMTA.

Last October, Dr Chan initiated consultations over the issues of benefit sharing, IPRs and SMTA, and made proposals on these issues in an attempt to "find a middle ground to bridge the wide divergences". The DG's proposals are contained in document EB 126/4. However, agreement remains elusive.

Developed countries wished to see voluntary benefit sharing with no links to virus sharing and to allow entities receiving biological materials from the WHO to make patent claims over the materials and parts thereof, as well as over the products developed using the biological materials. They were resistant to the idea of an SMTA being the contractual document for the sharing of biological materials, although developed countries and their laboratories commonly use it for the purpose of sharing viruses.

On the other hand, developing countries stressed the need for entities receiving biological materials from the WHO to commit to benefit sharing through SMTA, and for entities receiving biological materials to not claim IPRs over the biological materials, adding an exception, i. e. industry may claim IPRs over the products developed using the biological materials but such IPRs must be licensed to developing-country entities on a royalty-free basis.

A group of like-minded countries (LMG) including Bolivia, Brazil, Cuba, Egypt, India, Indonesia, Iran, Nigeria and Sri Lanka issued a joint statement at the end of the consultations. They stressed on a "sustainable solution", stating that "while ad hoc solutions, including donations were useful, it does not provide a sustainable systematic solution". The LMG also reaffirmed the "single undertaking approach that nothing is agreed until all issues are agreed", adding that a "middle ground should not lead us astray from a high ground' solution in the context of public health and particularly in the midst of a pandemic".

The LMG also noted that while they applauded the efforts of the DG "to engage in negotiations with industry, the central focus that should guide these efforts with industry should be the interests of public health and not the parameters of what the industry is willing to do". They stressed that while innovation was important, the benefits of innovation have to be accessible at an affordable price. On IPRs, the LMG reiterated their conviction that the WHO is mandated to consider issues of IPRs from an access perspective, adding that IPRs must be balanced in the context of rights and obligations including those pertaining to the public at large.

During the EB meeting, developing countries strongly supported the need for effective benefit sharing, SMTA, as well as stressed that IPRs should not impede public health.

India said that it supported virus sharing with the WHO network on the understanding that it benefits global public health and is matched by an equal and simultaneous commitment to share benefits. It added that genetic material should be part of the definition of biological material. Developing countries must have access to research, data and technology to develop products such as vaccines, drugs and reagents, contributing to overall accessibility and affordability, it further said.

It drew attention to the fact that countries wishing to import from the global vaccine manufacturers are required to enter into detailed contractual agreements that are confidential and absolve all liabilities with the adverse outcome vesting only with the importer. It added that such mandatory contractual obligations are neither transparent nor ethical and are against the principle of equity. It further said that it would like the WHO to share the agreement entered into with the originator vaccine manufacturers which would empower members who are purchasing vaccines.

It said that benefits such as the WHO stockpile of vaccines, medicines and other supplies are important in the short term but these are not "sustainable long term solutions", stressing the need to expand global capacity for manufacturing influenza vaccines including that in developing countries. Thus, technology transfer and capacity building should be given high priority, it said.

India also said that it was disturbed by newspaper reports claiming that members of SAGE had financial links with the pharmaceutical companies engaged in the development of H1N1 vaccines, adding that it had also seen reports claiming that swine flu was a "false pandemic".

(SAGE is charged with advising WHO on overall global policies and strategies, ranging from vaccine and technology, research and development, to delivery of immunization and its linkages with other health interventions).

Indonesia said the H1N1 pandemic has made the case for a global health response, adding that in times of global shortages, global cooperation can provide support by focusing on fair and equitable sharing of benefits. It further said that the IGM has made progress on certain principles such as commitment to share on an equal footing influenza viruses of human pandemic potential and the benefits. It stressed on the importance of ensuring that the PIP framework is concluded.

Malawi, on behalf of the members of the African Regional office (AFRO), said that while it appreciated the DG's proposals, it was their understanding that they did not engage in any negotiations on those proposals. It added that the IGM had made substantive progress but the DG's proposal to separate benefit sharing from virus sharing was a major departure.

Malawi said that Africa has numerous challenges and would like to see an international mechanism to ensure fair and equitable benefit sharing. It also called for an open-ended, inclusive and transparent negotiation process.

Bangladesh said that there was a need for a more predictable and sustainable mechanism for benefit sharing rather than relying on ad-hoc arrangements (referring to donations by industry). It said that Bangladesh was willing to share but it wanted to see clear and sustainable benefit-sharing with affected countries. It stressed on the agreed principle of equal footing - i. e, the Standard Material Transfer Agreement (SMTA) should apply to virus sharing and benefit sharing and should also apply to all entities, and the SMTA should be the only legally binding instrument. It added that the SMTA should not be limited to influenza vaccine manufacturers and benefit sharing should not be considered voluntary. It further stated that benefit-sharing provisions should be outlined in the SMTA.

It cautioned that the "middle ground" position pushed by the DG may lead to more ad hoc arrangements, also pointing out that certain conclusions in EB 126/4 do not capture the views of all Member states. It supported the call for open-ended consultations among Member states, stressing on the need to conclude the PIP framework.

Oman, on behalf of members of the Eastern Mediterranean region (EMRO), said that transparency in the exchange of clinical samples was important, as this would help to prepare vaccines. It however added that ensuring fair and equitable benefit sharing, and access to vaccines against the pandemic at accessible prices is a concern to EMRO. A fixed percentage of vaccines produced should be allocated to each country based on its population to ensure equitable distribution, it said, adding that IPRs should not be an issue when we are dealing with a pandemic.

Brazil said that it saw the future framework of virus and benefit sharing as allowing for rapid systematic sharing of virus, fair and equitable sharing of benefits, technology transfer and global improvement of laboratories. On benefit sharing, Brazil said this is a right of Member states and any benefit sharing agreement should be binding and enforceable and not be limited to influenza vaccine manufacturers. It added that Member states and the Secretariat should make efforts on reconvening the negotiating body before the WHA. Logistics and financial considerations should not hinder us, it said.

Mauritius also pointed out the need to clear the air with regard to media reports on SAGE links to pharmaceutical companies, since it may affect the decision of citizens whether vaccination is needed. WHO needs to provide necessary guidance, it said.

Uruguay said that it has not received the vaccines stocks requested from the Pan American Health Organisation (PAHO).

Mexico, one of the first few countries to be severely hit by the H1N1 outbreak and to share viruses, said that cooperation is essential in order to combat this disease. It said that even with a mechanism of sharing viruses, there has not been sharing of benefits. "We have limited stock of vaccines and only a few countries have access to it". It further added that it was essential that an agreement be reached on benefit sharing.

Japan stressed on voluntary contributions of benefits and that IPRs should be considered as an important incentive for innovation.

Hungary, on behalf of the European Union, said that international collaboration was paramount to a rapid response and that lessons learned from the H1N1 (outbreak) should be fed into future deliberations. On the issue of IPRs, Hungary said that it played an important role in promoting innovation, adding that IPR issues must be handled in collaboration with competent organizations such as the WTO and WIPO. It supported the intention of improving access to vaccines especially for those without production capacity but said that it was concerned about the mandatory linkage between virus sharing and benefit sharing and wished to see a mechanism based on voluntary contributions.

Responding to issues raised by India and Mauritius, Dr Chan said that there is a lot of rumour and misinformation and it is hurting countries, adding that "We have come out to refute this and state clearly what are the recommendations".

Dr Chan added that the WHO has a policy that requires experts to make a declaration of interest. All the experts that participate in SAGE have declared conflicts of interest, which are then shared with other experts in SAGE, she said, adding that is an important peer check and balance. "Whether or not experts give full disclosure is an ethical issue. Where we know that no full disclosure has been made, an immediate investigation will be conducted and this is what we have been doing," she said, adding: "We have special arrangements whereby we excluded certain participants and observers from the decision-making process".

In terms of real experts on influenza, there are not too many, she said, and thus, these experts are sought after for their professional experience by the industry, academic institutions and research institutions. "I would not deny the world in getting the best advise," Dr Chan added. "We will do our utmost to counter the misinformation and protect the independence of experts. It is my duty to guard against undue influences," Dr Chan said.

The issue of the link between pharmaceutical companies and SAGE has come about as a result of recent news reports revealing the apparent close ties between SAGE experts and the industry.

According to a news report dated 13 January by Nagrajan from TNN, "None of the WHO members on the vaccine board, barring one, declared any conflict of interest despite having extensive financial ties with the pharmaceutical companies in the form of research grants and consultancies".

The same news report mentions that the Danish Freedom of Information Act revealed that Prof. Juhani Eskola, a Finnish member of SAGE, received almost 6.3 million euros in 2009 from vaccine manufacturers for his vaccine research programme and that Danish journalists have reported on six other SAGE members with financial ties to various pharmaceutical companies.

The news report further draws attention to the fact that the "names and affiliations of members of SAGE and SAGE working groups are published on the WHO web-site together with meeting reports and declarations of interest submitted by the experts" but that it found no declaration of conflict of interest by the SAGE members on the WHO web-site.

Another news report by Pharma Times dated 6 January reported that the Parliamentary Assembly of the Council of Europe (PACE) is to hold an emergency debate and inquiry this month into the "influence" exerted by drug-makers on the WHO global H1N1 flu campaign.

It cites Dr Wodarg, a doctor and former SPD member of the German Bundestag, as charging that WHO, "in cooperation with some big pharmaceutical companies and their scientists, re-defined pandemics," removing the statement that "an enormous amount of people have contracted the illness or died" from its existing definition and replacing it by stating simply that "there has to be a virus, spreading beyond borders and to which people have no immunity".

Some delegates at the Executive Board said privately that they expected the issues raised in the news reports to be addressed during the review of the response to the H1N1 pandemic to be conducted by the WHO. +